Application Sponsors
ANDA 088922 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | TABLET;ORAL | 250MG | 0 | CHLORPROPAMIDE | CHLORPROPAMIDE |
FDA Submissions
| ORIG | 1 | AP | 1985-04-12 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1986-07-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1987-06-17 | |
LABELING; Labeling | SUPPL | 9 | AP | 1988-11-17 | |
LABELING; Labeling | SUPPL | 10 | AP | 1991-05-29 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1992-03-24 | |
LABELING; Labeling | SUPPL | 12 | AP | 1992-07-29 | |
LABELING; Labeling | SUPPL | 13 | AP | 1993-02-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1994-05-11 | |
LABELING; Labeling | SUPPL | 15 | AP | 1994-04-22 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-07-07 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2001-01-19 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-06-20 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-05-29 | |
LABELING; Labeling | SUPPL | 20 | AP | 2001-08-09 | |
LABELING; Labeling | SUPPL | 21 | AP | 2003-08-04 | |
Submissions Property Types
SUPPL | 4 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 16 | Null | 0 |
SUPPL | 17 | Null | 0 |
SUPPL | 18 | Null | 0 |
SUPPL | 19 | Null | 0 |
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 88922
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"CHLORPROPAMIDE","activeIngredients":"CHLORPROPAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CHLORPROPAMIDE","submission":"CHLORPROPAMIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)